Join Trial Testing Potential Cure for Type 1 Diabetes
The VX-264 trial is one of the most anticipated research projects in years for people with type 1 diabetes. The clinical study looks to gauge the effectiveness of implanted islet cells, which control blood sugar levels. The novel aspect of the treatment is an encapsulation device that protects the islet cells from the body’s immune system.
Clinical Trials Identifier: NCT05791201
Trial Name: A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes
Diabetes Type: Type 1
Trial Sponsor: Vertex Pharmaceuticals / UHealth Diabetes Research Institute
What is the trial researching?
While islet cell transplantation is one of the most promising potential cures for type 1 diabetes, the body’s immune system response will attack the transplanted cells, presenting a daunting challenge. The transplantation method used in the VX-264 study aims to provide years of blood sugar control akin to a functioning pancreas – but without the need for immunosuppressants.
In the VX-264 study, the cell-derived islet cells are encapsulated with a device to protect them from the recipient’s immune system. In a surgical procedure under general anesthesia, the devices are implanted behind the muscles in the abdominal wall.
A related trial, the VX-880 study – which uses the same cell-derived beta cells, but does require the use of immunosuppressive drugs to fight off rejection – has shown promising results. Vertex recently announced that all 12 of the patients in the study began producing insulin by day 90. The three patients who had passed the year mark after treatment have continued to produce insulin.
Why is this trial important?
Current islet transplantation methods require the person who receives the transplant to take lifelong immunosuppressive drugs to protect the transplanted cells. The drugs, which are taken daily, come with additional risks of infection and certain types of cancer.
In addition, using current transplant methods, nearly 60% of the cells are rejected by the body. The VX-264 study is designed to alleviate the need for anti-rejection drugs, while the encapsulation protects the cells and their ability to regulate blood sugar and deliver insulin.
Are you interested?
The trial is currently recruiting people with type 1 diabetes. Here are the criteria for qualifying:
- Have type 1 diabetes for five years or more
- Age 18-65
- On a stable treatment for diabetes
- Use continuous glucose monitoring for four weeks before being screened and be willing to use CGM during the study
- No previous islet cell transplant, organ transplant, or cell therapy
The study will be conducted through May 2026, in Chicago, Boston, and Philadelphia. See a full list of inclusion/exclusion criteria or find out more about the trial.
Learn more about new treatments for type 1 diabetes here: